AI development agency
We Build
AI Solutions for
Healthcare &
MedTech
Engineering consultancy delivering end-to-end solutions: AI models, web platforms, mobile apps, enterprise systems, and firmware. You dream. We build.
100%
Focus on regulated industries
Boutique
Specialized expertise
5
Regulatory approvals
FDA, CE Mark, UKCA, ISO, IEC
Why Visionary Companies Choose Us
We deliver production-ready AI systems that follow regulatory guidelines and scale to millions of users or devices
Full-Stack Excellence
Complete solutions: AI models, web apps, mobile apps, enterprise systems, and embedded firmware. One team, everything you need.
Regulatory DNA
FDA 510(k), CE Mark, UKCA certified. Software developed in compliance with IEC 62304 and ISO 13485 standards.
Production Scale
Real-time processing for mission-critical healthcare and financial systems. Scale to millions of users or devices.
Zero Trust Security
We implement zero-trust architecture in your cloud infrastructure and applications, ensuring SOC2 Type II and HIPAA compliance while meeting industry best practices.
From Vision to Production
We deliver complete solutions from proof-of-principle/MVPs to production applications. Our structured approach ensures regulatory compliance, technical excellence, and rapid time-to-market for healthcare, fintech, and enterprise ventures.
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Initial Consultation
A focused introductory call to understand your vision, challenges, and goals. We discuss your timeline, budget considerations, and whether you need a rapid POC or a production-ready system. This is a no-commitment conversation to explore how we can help.
Assessment & Analysis
We evaluate your existing tech stack (if any), data infrastructure (if any), and regulatory landscape. We deliver a comprehensive assessment document outlining AI opportunities, technical requirements, POC vs production pathways, and a detailed proposal for your development needs.
Strategy Development
We design a comprehensive roadmap covering AI model selection and evaluation, with development of custom models when necessary, as the majority of clients require integration of extant models rather than bespoke training from scratch. This includes full-stack applications and technical aspects of regulatory compliance where applicable. For POCs, we focus on rapid validation. For production, we define technical milestones supporting FDA/CE compliance pathways.
DevOps & Infrastructure
We set up secure cloud infrastructure with HIPAA-compliant environments, automated CI/CD pipelines, monitoring systems, and disaster recovery. We handle containerization, orchestration, load balancing, and ensure your system scales seamlessly while maintaining security and compliance.
Implementation
We build your complete solution: evaluating and selecting AI models, with training of custom models when necessary, alongside developing web and mobile applications, creating backend APIs, and even embedded firmware. For production medical software, we follow IEC 62304 standards. For POCs, we prioritize speed and functionality while maintaining code quality.
Ongoing Support
We provide continuous technical leadership, from interim CTO services to dedicated engineering support. We handle model monitoring, software updates, and for production systems, technical maintenance supporting regulatory compliance. We help scale your internal AI capabilities through knowledge transfer.
Ready to transform your vision into reality?
Complete Solutions, Not Just AI
We build everything: AI models, web platforms, mobile apps, enterprise backends, and embedded firmware. From rapid prototypes to production-ready systems with complete technical documentation.
Production Build
Full production system with regulatory compliance
Proof of Concept
Validate your AI idea with a working prototype
FDA Technical Package
Complete software technical documentation for 510(k) - V&V, cybersecurity, STRIDE, disaster recovery
Interim CTO
Full or fractional CTO engagement for strategic AI leadership ($30K/FTE, fractions available)
Need something custom?
Let's discuss your needsFAQ
Frequently Asked Questions
Everything you need to know about partnering with Vintergatan. Can't find what you're looking for? Contact our team directly.
We specialize in regulated industries where failure isn't an option - healthcare, medical devices, and critical infrastructure. We've shipped enterprise systems that are deployed and used in several countries. Our specialty is navigating complex regulatory requirements while delivering production-ready AI systems.
We deliver functional prototypes in 4-6 weeks using our battle-tested frameworks and playbooks. Our rapid prototyping process includes technical feasibility, regulatory pathway assessment, and a clear go/no-go recommendation with cost projections for the full build.
Yes. We've worked with pre-seed and seed companies, both bootstrapped and externally funded. We love startups. For exceptional startups with limited funding, we're open to serving as Technical Advisor and waiving or reducing our fees. We understand the unique challenges of building AI products with limited resources.
We have successfully completed FDA 510(k) submissions, CE Mark certifications, and HIPAA/SOC2 audits. We maintain a library of pre-validated playbooks that accelerate regulatory approval. We understand IEC 62304, cybersecurity requirements, and the complete technical documentation needed for submissions.
Absolutely. Beyond building your systems, we can help recruit, train, and manage your technical team. Our interim CTO service includes hiring plans, technical interviews, and knowledge transfer. We focus on building sustainable internal capabilities for long-term success.
We're technology-agnostic but prefer AWS for infrastructure, Next.js or Nuxt for web applications, and Capacitor or Flutter for cross-platform mobile app development due to our proven success with these technologies. For AI/ML, we work with PyTorch, TensorFlow, and JAX. We choose the stack that best fits your requirements.
All IP developed belongs to you. While we generally don't sign NDAs for initial discussions (for practical reasons), we sign comprehensive NDAs once we commit to working together. We can work under your company's security protocols. Our team has experience handling sensitive healthcare and financial data with appropriate security measures.
Ready to Ship
Production AI?
No commitment required • Expert consultation • NDA protected